FDA.reportPublic FDA data

Back and Large Extra Strength Cold-Hot Medicated Patches

Product NDC
63868-294
Requested package NDC
63868-294-05
11-digit product format
638680294
Labeler code
63868
Product ID
63868-294_ef56d733-c4c5-1938-e053-2995a90a6343
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 g/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-29463868-294-05IInactivated by FDA2026-07-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-294-05Back and Large Extra Strength Cold-Hot Medicated Patches1 in 1 POUCHPATCH15
63868-294-05Back and Large Extra Strength Cold-Hot Medicated Patches5 in 1 BOXPATCH55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-294-05EA - Each63868-294439c6eb9-46a0-45c8-9f0c-783d7023e01412022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-294BACK AND LARGE EXTRA STRENGTH COLD-HOT MEDICATED PATCHES (MENTHOL) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]5Legacy NDC, 2 package rows20241220_65b713ca-b666-4138-8903-9d9d59a185f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN65b713ca-b666-4138-8903-9d9d59a185f65
420222menthol 0.05 MG/MG Medicated PatchSCD65b713ca-b666-4138-8903-9d9d59a185f65
420222menthol 5 % Medicated PatchSY65b713ca-b666-4138-8903-9d9d59a185f65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-294-05638680294055 POUCH in 1 BOX (63868-294-05) > 1 PATCH in 1 POUCH5 pouch2019-01-010000-00-00NoNoCurrent